NANO COMPOSITE

Material, Tooth Shade, Resin

COSMEDENT, INC.

The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Nano Composite.

Pre-market Notification Details

• Device ID: K070583
• 510k Number: K070583
• Device Name: NANO COMPOSITE
• Classification: Material, Tooth Shade, Resin
• Applicant: COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611
• Contact: James L Sandrik
• Correspondent: James L Sandrik; COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-01
• Decision Date: 2007-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D779600SB30	K070583	000
D7796002351	K070583	000
D7796001MI0	K070583	000
D7796001LI0	K070583	000
D7796001D30	K070583	000
D7796001D20	K070583	000
D7796001C40	K070583	000
D7796001C30	K070583	000
D7796001C20	K070583	000
D7796001C10	K070583	000
D7796001B10	K070583	000
D7796001B00	K070583	000
D7796001A40	K070583	000
D7796001A30	K070583	000
D7796001A20	K070583	000
D7796002A11	K070583	000
D7796002A21	K070583	000
D779600A350	K070583	000
D7796002S31	K070583	000
D7796002MI1	K070583	000
D7796002LI1	K070583	000
D7796002D31	K070583	000
D7796002D21	K070583	000
D7796002C41	K070583	000
D7796002C31	K070583	000
D7796002C21	K070583	000
D7796002C11	K070583	000
D7796002B11	K070583	000
D7796002B01	K070583	000
D7796002A41	K070583	000
D7796002A31	K070583	000
D7796001A10	K070583	000